Indicators for Monitoring National Drug Policies
(1999; 250 pages) [French] View the PDF document
Table of Contents
View the documentACKNOWLEDGEMENTS
Open this folder and view contentsCHAPTER I: Introduction
Open this folder and view contentsCHAPTER II: Development of the manual
Close this folderCHAPTER III: Model lists of indicators
View the documentBackground information
View the documentStructural indicators
View the documentProcess indicators
View the documentOutcome indicators
Open this folder and view contentsCHAPTER IV: Methodology for indicator calculation
Open this folder and view contentsCHAPTER V: Detailed presentation of indicators
Open this folder and view contentsANNEX 1: Data collection forms
View the documentANNEX 2: Glossary
View the documentANNEX 3: Table of random numbers
View the documentBACK COVER
 

Structural indicators

These 50 indicators provide qualitative information on the basic structures that are considered necessary for implementing a national drug policy. The indicators check whether the basic structures/systems/mechanisms under each key component exist in the country. They do not evaluate the functioning of these structures (for example, these indicators check whether quality control facilities exist, but not whether they work efficiently). The performance of the structures is assessed with the process indicators. The structural indicators monitor the main aspects of the seven key components of drug policy:

• legislation and regulation;
• essential drug selection and drug registration;
• drug allocation in the health budget and public sector financing policy;
• public sector procurement procedures;
• public sector distribution and logistics;
• pricing policy;
• information and continuing education on drug use.

The structural indicators are answered "Yes" or "No" on the basis of information usually available at the central level. When answered "Yes", they do not provide any more a measure for progress, except to check that things do not deteriorate. Their main significance lies in the negative answers. Many "No" answers suggest that improvements are required in institutional capacity if the drug sector is to make significant progress towards achieving overall policy objectives. For certain indicators, and according to specific country needs, the monitoring unit can decide to collect some written statements to understand the situation better or to quantify these indicators.

The structural indicators may be analysed and interpreted one by one; however, structural and process indicators have been designed in such a way that it is more important to analyse all those related to a specific key component together, as shown in the table below. This means that structural indicators are related to one another within each component and should be analysed together, e.g. the results of ST1 to ST11 should be reviewed together to obtain a complete picture of the situation in terms of legislation and regulation. In addition, the structural indicators should be analysed with the process indicators for each component in order to understand what is working and what is not.

Key component

ST

PR

Legislation and regulation.

ST 1 - ST 11

PR 1 - PR 7

Essential drug selection and drug registration.

ST 12 - ST 18

PR 8 - PR 13

Drug allocation in the health budget/public sector financing policy.

ST 19 - ST 23

PR 14 - PR 18

Public sector procurement procedures.

ST 24 - ST 30

PR 19 - PR 26

Public sector distribution and logistics.

ST 31 - ST 36

PR 27 - PR 29

Pricing policy.

ST 37 - ST 41

PR 30 - PR 32

Information and continuing education on drug use.

ST 42 - ST 50

PR 33 - PR 38

The structural indicators can be used for assisting national and international decision-makers in formulating strategies and designing interventions to improve the pharmaceutical sector. They can be used in comparing the implementation of pharmaceutical policies in different countries. Structural indicators can also be used for advocacy purposes to increase government and donor support to the drug sector.

Field experience shows that structural indicators can be collected in a few days if adequate access exists to key persons in the pharmaceutical sector (public and private sectors). A one-page description of each structural indicator is provided in Chapter V and a model data summary form is provided in Annex 1 (Summary Form 2).

Legislation and regulation

ST1:

Is there an official national drug policy document updated in the past 10 years?

ST2:

Is there drug legislation updated in the past 10 years?

ST3:

Have regulations based on the drug legislation been issued?

ST4:

Is there a drug regulatory authority whose mandate includes registration and inspection?

ST5:

Is there a licensing system to regulate the sale of drugs (wholesalers, pharmacists, retailers)?

ST6:

Are pharmacists legally entitled to substitute generic drugs for brand name products?

ST7:

Are there legal provisions for penal sanctions?

ST8:

Is there a checklist for carrying out inspections in different types of pharmaceutical establishments?

ST9:

Are there any institutions within or outside the country where quality control is carried out?

ST10:

Is the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce used systematically?

ST11:

Are there controls on drug promotion based on regulations and consistent with the WHO Ethical Criteria for Medicinal Drug Promotion?

Essential drug selection and drug registration

ST12:

Is there a national essential drugs list (EDL)/formulary using INN officially adopted and distributed countrywide?

ST13:

Is there an official drug committee whose duties include updating the national essential drugs list (EDL)?

ST14:

Has the national essential drugs list (EDL)/formulary been updated and distributed countrywide in the past five years?

ST15:

Do drug donations comply with the national essential drugs list (EDL)?

ST16:

Are there formal procedures for registering drugs?

ST17:

Is there a drug registration committee?

ST18:

Is drug registration renewal required at least every five years?

Drug allocation in the health budget/public sector financing policy

ST19:

Is the public drug budget spent per year more than 20% of the ministry of health operating budget spent per year for the last three years?

ST20:

Is the public drug budget spent per capita per year more than US$ 1.00 per year for the last three years?

ST21:

Is the public drug budget spent for national hospitals less than 40% of the total public drug budget spent for the last three years?

ST22:

Has the public drug budget spent per capita increased in the last three years?

ST23:

Are there any financing systems in addition to the public drug budget that contribute to the provision of drugs in the public sector?

Public sector procurement procedures

ST24:

Are drugs usually procured in the public sector through competitive tender?

ST25:

Is there a system for monitoring supplier performance?

ST26:

Is most of the tendering done under international nonproprietary name (INN)?

ST27:

Does the procurement unit receive foreign currency in less than 60 days (from request to release)?

ST28:

Is procurement in the public sector limited to drugs on the national essential drugs list (EDL)?

ST29:

Is the average lead time (from order to receipt at central level) less than eight months?

ST30:

Is procurement based on a reliable quantification of drug needs?

Public sector distribution and logistics

ST31:

Are good storage practices observed in the central procurement/distribution unit and/or major regional warehouses?

ST32:

Is the information recorded on the stockcards for a basket of drugs11 the same as the quantity of stock in store?

ST33:

Are the stocks for a basket of drugs within their expiry dates in the central procurement/distribution unit and/or major regional warehouses?

ST34:

Have all incoming products been physically inspected for the last three deliveries in the central procurement/distribution unit and/or in major regional warehouses?

ST35:

Are only drugs which are on the national essential drugs list (EDL) in stock in the central procurement/distribution unit and/or in major regional warehouses?

ST36:

Are 80% or more of the vehicles of the central procurement/distribution unit and/or major regional warehouses in working condition?

11 A basket of drugs is provided as an example in Chapter IV

Pricing policy

ST37:

Are drug prices regulated in the private sector?

ST38:

Is there at least one major incentive for the private sector to sell essential drugs at low cost?

ST39:

Is the total margin used by wholesalers and retailers less than 35% of the CIF price?

ST40:

Is there a system for monitoring drug prices?

ST41:

Are essential drugs under INN or generic name sold in private drug outlets?

Information and continuing education on drug use

ST42:

Is there a national publication (formulary/bulletin/manual, etc.), revised within the past five years, providing objective information on drug use?

ST43:

Is there a national therapeutic guide with standardized treatments?

ST44:

Is the concept of essential drugs part of the curricula in the basic training of health personnel?

ST45:

Is there an official continuing education system on rational use of drugs for prescribers and dispensers?

ST46:

Is there a drug information unit/centre?

ST47:

Does the drug information unit/centre (or another independent body) provide regular information on drugs to prescribers and dispensers?

ST48:

Are there therapeutic committees in the major hospitals?

ST49:

Are there public education campaigns on drug use?

ST50:

Is drug education included in the primary/secondary school curricula?

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